Assessment of Sleep Complaints in Brain Tumor Survivors

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Přihlášení Registrace

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PostaveníDokončeno

Sponzoři

St. Jude Children's Research Hospital

KLINICKÉ HODNOCENÍ: NCT01102998

BioSeek: NCT01102998

Klíčová slova

Abstraktní

Survivors of pediatric brain tumors are noted to have increased rates of excessive daytime sleepiness. However, very little data are available regarding the specific sleep disturbances of pediatric brain tumor survivors. Children ages 8 to 18 years of age who are at least 5 years from diagnosis and at least 2 years post treatment or observation only for a brain tumor will be targeted to assess the prevalence of sleep complaints.

The study focuses on the following objectives:

- To estimate sleep disturbance in a cohort of pediatric brain tumor survivors.

- Estimate the rates of parent- and self-reported excessive daytime sleepiness in pediatric brain tumors

- Estimate the rates of parent-reported sleep-disordered breathing, including snoring and witnessed apneas, in pediatric brain tumor survivors

- Estimate the rates of parent- and self-reported behavioral sleep problems, including nocturnal enuresis, bedtime resistance, nighttime awakenings, nightmares, and fatigue in pediatric brain tumor survivors.

The Study focuses on the following secondary objectives:

- To describe bedtime patterns and sleep hygiene of pediatric brain tumor survivors.

- Estimate the typical parent- and self-reported weekday sleep duration of pediatric brain tumor survivors

- Estimate the typical parent- and self-reported weekend sleep duration of pediatric brain tumor survivors and if it differs from the weekday sleep duration

- Estimate the typical parent- and self-reported consistency of sleep hygiene in pediatric brain tumor survivors

Popis

This non-therapeutic single arm study will characterize the prevalence and types of sleep complaints of pediatric brain tumor survivors. Brain tumor survivors ages 8 to 18 years who are at least 5 years post diagnosis and 2 years post active therapy and their parents/guardians will be approached to participate during clinic visits. If the patient and guardian agree to participate, they will be administered three questionnaires in the clinic during the patient's visit. From the medical record, the following variables will be utilized to characterize the subjects and estimate which groups are at greatest risk of sleep disturbances:

- Specific brain tumor diagnosis

- Location of tumor (cerebral hemispheres, parasellar region, posterior fossa, or spine)

- Age at diagnosis

- Obesity status

- Treatment modality (surgery, radiation therapy, and/or chemotherapy vs. observation only)

Termíny

Poslední ověření:	10/31/2013
První předloženo:	04/11/2010
Odhadovaná registrace vložena:	04/11/2010
První zveřejnění:	04/12/2010
Poslední aktualizace byla odeslána:	11/14/2013
Poslední aktualizace zveřejněna:	11/17/2013
Aktuální datum zahájení studie:	03/31/2010
Odhadované datum dokončení primární:	08/31/2012
Odhadované datum dokončení studie:	03/31/2013

Stav nebo nemoc

Brain Tumors

Fáze

Skupiny zbraní

Paže	Intervence / léčba
Brain Tumor Survivors Brain tumor survivors ages 8 to 18 years who are at least 5 years post diagnosis and at least 2 years post active therapy or observation and their parents/guardians will be approached to participate during clinic visits.

Kritéria způsobilosti

Věky způsobilé ke studiu	8 Years Na 8 Years
Pohlaví způsobilá ke studiu	All
Metoda vzorkování	Non-Probability Sample
Přijímá zdravé dobrovolníky	Ano
Kritéria	Inclusion Criteria: - Age ≥8 to ≤ 18 years of age - Brain tumor survivor - ≥5 years post diagnosis - ≥2 years post active cancer-directed therapy or observation only - Parents speak and read English fluently - Potential participant reads English fluently - Potential participant/guardian willing to sign consent Exclusion Criteria: - Survivor of any cancer other than a brain tumor.

Výsledek

Primární výsledná opatření

1. Sleep disturbance in a cohort of pediatric brain tumor survivors. [2 years]

Estimate the rates of parent- and self-reported excessive daytime sleepiness in pediatric brain tumors Estimate the rates of parent-reported sleep-disordered breathing, including snoring and witnessed apneas, in pediatric brain tumor survivors Estimate the rates of parent- and self-reported behavioral sleep problems, including nocturnal enuresis, bedtime resistance, nighttime awakenings, nightmares, and fatigue in pediatric brain tumor survivors.

Assessment of Sleep Complaints in Brain Tumor Survivors

Klíčová slova

nádor mozku

rakovina

únava

chrápání

somnolence

enuréza

enuresis

obezita

antimykotikum

chemoterapie